Index
A
Acceptance of causal relation, 16, 32-33
Acquired immune deficiency syndrome, 294
Acute disseminated encephalomyelitis, 34, 35, 36, 37, 45, 47, 83, 84, 85, 86
See also Encephalomyelitis
Adverse Effects of Pertussis and Rubella Vaccines,4, 59
executive summary, 310-317
Adverse events
causal assessment of, 23-24, 25-26
diphtheria vaccination, 16, 17, 73, 74-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108
hepatitis B vaccination, 217-218, 220-221, 223, 224-226, 228, 229-230, 306
Hib vaccination, 239-241, 242, 244-246, 247, 248-249, 250-260
individual differences, 307
measles-mumps-rubella vaccination, 127, 131-134, 144, 164, 165-167, 172-175
measles vaccination, 16, 17, 123-129, 136-140, 147-148, 149-150, 151-152, 156, 160, 164, 165-168, 170, 171-172, 198-199
mumps vaccination, 131-134, 144, 146, 154-158, 161-162, 164, 165-168
polio vaccination, 17, 190-194, 198-199, 200-203
rabies vaccination, 44
research needs, 307-308
risk-modifying factors, 3
rubella vaccination, 4-5
swine flu vaccination, 42-44
tetanus vaccination, 16, 17, 70-71, 73-77, 78-81, 83-85, 87-88, 90 , 91-92, 94-97, 98-99, 100, 104-108
See also Deaths;
specific adverse event
Advisory Committee on Immunization Practices, 121, 189, 213, 238, 278
Afebrile seizures, 53, 78, 144
Age-related effects
hepatitis B vaccination response, 214
in Hib vaccinations, 236-237, 240
Age-specific incidence, 17
in Guillain-Barré syndrome, 46-47
Aids to Interpretation of the Vaccine Injury Table, 48-49, 50
American Academy of Pediatrics, 121, 176, 189, 213, 238
Analytic bias, 21
Anaphylaxis, 26
causality, 16, 17, 108, 109, 175-176, 205, 230-231, 262-263
clinical description, 59-61, 100, 170, 204, 228, 261
diphtheria vaccination and, 17, 100-110, 288, 290
fatal outcomes, 170, 231, 261, 288, 290, 292, 294-295, 300
hepatitis B vaccination and, 17, 228-231, 300
Hib vaccination and, 262-263
measles-mumps-rubella vaccination and, 17, 170-176, 292
measles vaccination and, 16, 175, 292
mumps vaccination and, 176
polio vaccination and, 204-205
risk-modifying factors, 109, 176, 231
tetanus vaccination and, 17, 100-110, 290
Antibody-antigen reaction
in anaphylaxis, 60-61
in arthritis, 95
Arthus type, 61-62
in delayed-type hypersensitivity, 62
in hepatitis B serum-like sickness, 223-224, 227
in hepatitis B vaccine-induced anaphylaxis, 228-229
in Hib vaccination, 240-241, 251-253
in measles, 121-122
in normal tissue, 61
normative, 63
in tetanus vaccination, 70-71, 101
Arthritis, 17
diphtheria-tetanus vaccination and, 95-97
epidemiology, 222
hepatitis B vaccination and, 223-227
in tetanus vaccination, 70-71
causality, 134-135
clinical description, 130
incidence, 130
mumps vaccination and, 130-135
Attributable risk, 27
B
Bayesian analysis, 25
Bias
analytic, 21
information, 21
systematic, 21
Biologic gradient, 21
anaphylaxis, 101-104, 170-171, 228-229, 230, 262
arthritis, 95, 97, 223-224, 227
demonstrated. 28
demyelinating diseases, 47-48, 84, 199, 220
diabetes mellitus, 155-156, 159
early-onset Hib disease, 251-252
encephalopathy, 73, 77, 123, 129
erythema multiforme, 98
Guillain-Barré syndrome, 87, 151, 216, 219, 244, 246
immunosuppression, 64
neuropathy, 90-91
optic neuritis, 147-148
poliomyelitis, 191
residual seizure disorder, 79, 142
sensorineural deafness, 146
subacute sclerosing panencephalitis, 136
thrombocytopenia, 164-165, 248
transverse myelitis, 149, 196, 199, 242
Brachial neuritis, 54-55
diphtheria-tetanus vaccination and, 16, 90, 91, 92, 93-94
C
Campylobacter jejuni, 39
Canada, 131, 132, 144, 161, 166, 173
Case-control studies, 29
Case reports and uncontrolled studies, 5
absence of, 22
anaphylaxis, 104-108, 171-175, 229, 262
aseptic meningitis, 131-134
brachial neuritis, 91-92
demyelinating diseases, 84-85, 221
diabetes mellitus, 156-158
early-onset Hib disease, 253-254, 256-260
encephalopathy, 74-75, 123-129
erythema multiforme, 98-99
evaluation of, 23-26
fatal outcomes, 275, 287-289, 291-294, 296-298, 300, 301
Guillain-Barré syndrome, 87-88
infantile spasms, 81
mononeuropathy, 91
multiple sclerosis, 221
orchitis, 161-162
residual seizure disorder, 79-81, 142-145
role of, 22
sensorineural deafness, 146
subacute sclerosing panencephalitis, 136-138
thrombocytopenia, 165-167, 248-249
transverse myelitis, 149-150, 198-199, 242
Causality
anaphylaxis, 16, 17, 108, 109, 110, 175-176, 205, 230-231, 262-263
arthritis/arthropathy, 97, 226-227
aseptic meningitis, 134-135
Can It? assessment, 20-23
combination vaccines, 5
definitions, 19-20
demyelinating diseases, 47-48, 85-86, 222
diabetes mellitus, 159
early-onset Hib disease, 260-261
encephalopathy, 16, 77-78, 129-130
erythema multiforme, 99
evidence for determination of, 5, 22-23, 27-33
fatal outcomes, 16, 17, 109-110, 205-206, 231, 263, 276-277, 277-278, 289-290, 294-295, 298-299, 300-301, 302
focal lesions, 36-37
Guillain-Barré syndrome, 16, 17, 88-89, 109, 110, 153, 203-204, 219 , 246
Haemophilus influenzae type b, 16, 17
Koch's postulates, 19
measles vaccine-strain viral infection, 17, 176-177, 291, 294-295
multivalent vaccines, 4
optic neuritis, 85, 86, 148-149, 222
orchitis, 163
plausibility, 5
poliomyelitis, 194-195
research needs, 17
residual seizure disorder, 81-82, 145
sensorineural deafness, 147
subacute sclerosing panencephalitis, 140-142
sudden infant death syndrome, 16, 109, 110, 287, 289, 290, 299, 300 , 301, 302
thrombocytopenia, 17, 168-169, 176-177, 205, 249-250
transverse myelitis, 85, 86, 150-151, 199-200, 222, 243
Will It? assessment, 20, 26-27
Centers for Disease Control and Prevention, 2, 28, 150, 190, 191-193, 195, 217, 274, 279, 297, 307
Clinical trials, 5
hepatitis B vaccines, 214-216, 218
Hib vaccines, 243, 246, 249, 254-260, 262
measles vaccine, 129, 140, 145, 162
rabies vaccine, 35-36
research needs in, 308
role of, 30
Coding Symbols for Thesaurus of Adverse Reaction Terms, 279
Cohort studies, 29
Combination vaccination, 5
immune system reactions and, 62-65
research needs, 307
Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, 3, 4-5, 16, 31-32, 310-317
Compensation for vaccine-related injury, 2
Contamination of vaccine, 275-276
Controlled observational studies, 5
anaphylaxis, 262
diabetes mellitus, 158
early-onset Hib disease, 254, 256-260
Guillain-Barré syndrome, 201-203, 246
orchitis, 162
research needs in, 308
residual seizure disorder, 81
role of, 29
subacute sclerosing panencephalitis, 138-140
sudden infant death syndrome, 287
thrombocytopenia, 167-168, 249
transverse myelitis, 243
Coxsackie virus, 155-156
Cutter incident, 275
Cytomegalovirus, 39
D
Data sources, 3-5, 16, 23, 28, 322-323
electronic databases, 318-321
research needs, 307-308
Vaccine Adverse Event Reporting System as, 278-286
Deafness. See Sensorineural deafness
Deaths
classification of, 274-278
data sources, 274
DPT vaccination and, 109, 287-290
DT vaccination and, 109, 110, 289-290
hepatitis B vaccination and, 231, 300-301
Hib vaccination and, 263, 301-302
measles fatality rate, 118
measles-mumps-rubella vaccination and, 176-177
measles vaccination and, 17, 176, 177, 294-295
meningitis fatality rate, 236
polio vaccination and, 17, 205-206, 296-299
research needs, 307
tetanus vaccination and, 109, 110, 290
Vaccine Adverse Event Reporting System data, 282-286
See also Sudden infant death syndrome
Demonstrated plausibility, 5
Demyelinating diseases, 17, 34-36
biologic plausibility, 84
clinical description, 83
diphtheria vaccination and, 85-86
hepatitis b vaccination and, 219-222, 306
measles and, 147-148
multiple sclerosis, 36, 219, 220-221, 222, 241, 306
optic neuritis, 36, 37, 83, 85, 86, 147-149, 220, 221, 222, 306
tetanus vaccination and, 85-86
See also Acute disseminated encephalomyelitis;
Guillain-Barré syndrome;
Transverse myelitis
Diabetes mellitus
clinical description, 153
epidemiology, 153
measles vaccination and, 154, 156-159
mumps vaccination and, 154-159, 306
viral infection and, 153-154, 155-156
Diagnosis
acute disseminated encephalo-myelitis, 36
aseptic meningitis, 130
brachial neuritis, 54
encephalopathy, 48-50
Guillain-Barré syndrome, 37-39, 40-42, 45-46
Hib disease, 239
immunologic reaction classifications, 59
measles, 118
mononeuropathy, 54
neuropathy, 90
residual seizure disorder, 78
seizures, 53
subacute sclerosing panencephalitis, 51
vaccine-associated poliomyelitis, 191
Didymitis. See Orchitis
Diphtheria, 68-69
Diphtheria-pertussis-tetanus vaccination, 4, 5, 63-64, 96, 101, 107 , 150, 237, 293
encephalopathy and, 73
in fatal outcomes, 287-290
immunization schedules, 69-70
sudden infant death syndrome and, 109, 276, 287, 289, 295, 296
See also Diphtheria vaccination;
Tetanus vaccination
Diphtheria-tetanus vaccination, 4, 72
anaphylactic reactions, 101, 107-108
as cause of death, 109, 110, 289-290, 296
deaths and, 287-289
encephalopathy and, 74-78
Guillain-Barré syndrome and, 88-89
immunization schedule, 70
seizures and, 79-82
sudden infant death syndrome and, 289
Td vs., 73
See also Diphtheria vaccination
Diphtheria vaccination, 2
acute disseminated encephalo-myelitis and, 83
anaphylaxis and, 100-110
arthritis and, 95-97
biologic effects, 70-72
brachial neuritis and, 16
demyelinating diseases and, 83-86
development of, 69
encephalopathy and, 72-78
erythema multiforme and, 98-99
Guillain-Barré syndrome and, 87-90
hypersensitivity reaction, 71-72
immunization schedule, 71
infantile spasms and, 16, 81-82
lot-specific reactions, 77, 305
mutant toxins, 305
neuropathy and, 90, 91-92, 93-94
research needs, 305
residual seizure disorder and, 78-82
response phases, 251
sudden infant death syndrome and, 109, 110
See also Diphtheria-pertussis-tetanus vaccination;
Diphtheria-tetanus vaccination;
Td vaccination
Disseminated intravascular coagulation, 248
Dose-response effects, 21
DPT. See Diphtheria-pertussis-tetanus vaccination
DPT: A Shot in the Dark,1
"DPT: Vaccine Roulette,"; 1
Dysgammaglobulinemia, 291, 295
E
Ecologic studies, 29
Egg allergy, 170-171, 173-174, 176
Encephalitis
measles vaccination and, 292, 293
mumps vaccination and, 123
See also Encephalopathy
Encephalomyelitis, 26, 34, 35-36, 45
See also Demyelinating diseases;
Encephalopathy
Encephalopathy, 16
diphtheria vaccination and, 73-78
immunosuppressive measles, 129
measles vaccination and, 123-130
subacute sclerosing panencephalitis, 51-52
tetanus vaccination and, 73-78
vaccine-related fatal outcomes, 293
combining, 30-31
evidentiary role of, 21, 22-23, 27, 32-34
See also Clinical trials;
Controlled observational studies
Epidemiology
age-specific incidence, 17
arthropathy, 222
bacterial meningitis, 236
brachial neuritis, 55
diabetes mellitus, 153
encephalitis, 49
epilepsy, 142
Guillain-Barré syndrome, 46-47, 86, 151, 200, 216, 244
hepatitis B chronic carriers, 211
Hib disease, 236
insulin-dependent diabetes mellitus, 153
research needs, 307-308
subacute sclerosing panencephalitis, 52, 135-136
thrombocytopenia, 163-164, 247
transverse myelitis, 37, 83, 85, 149, 196, 220, 241
vaccine-associated polio, 191-193, 195
seizures in, 53
See also Residual seizure disorder
Erythema multiforme
clinical description, 98
diphtheria-tetanus vaccination and, 99
hepatitis B vaccination and, 225
Erythema nodosum, 225
Evidence
algorithms in assessment of, 24
Bayesian analysis of, 25
in Can It? assessment, 20-23
clinical trials as, 30
controlled studies as, 29
in Did It? assessment, 23-26
encephalopathy, 49
meta-analysis, 30-31
uncontrolled studies as, 28-29
See also Data sources
Experimental allergic encephalo-myelitis, 35
Experimental allergic neuritis, 35-36
Experimental studies, 30
See also Clinical trials
F
Febrile seizures, 53, 78, 79, 80, 144, 145
Fevers, 53
Food and Drug Administration, U.S., 2, 28, 249, 274, 279, 283
G
Gamma globulin, 119
Gender differences
in hepatitis b vaccine-induced anaphylaxis, 228
in SSPE incidence, 52
Genetic factors, in diabetes susceptibility, 153-154
Germany, 74-75, 92, 126, 134, 138, 152, 157-158, 159, 161-162, 166 , 172-173, 194, 288, 292, 298
Guillain-Barré syndrome, 16, 17, 26, 35
biologic plausibility, 47-48, 87, 200, 216, 244
causality, 17, 88-89, 109, 110, 153, 203-204, 219, 246
clinical description, 37-39, 45, 86, 151, 200, 216, 243-244
diphtheria vaccination and, 16, 87-90, 109, 110, 286
DPT vaccination and, 288
DT vaccination and, 290
electrodiagnostic criteria, 38-39, 43
epidemiology, 46-47, 86, 151, 200, 216, 244
fatal outcomes, 109, 110, 205, 206, 288, 290, 296, 298-299, 307
hepatitis B vaccination and, 216-219, 306
Hib vaccination and, 244-246
measles vaccination and, 151-153
pathogenesis, 45-46
polio vaccination and, 200-206
rabies vaccination and, 44
research needs, 306-307
risk-modifying factors, 89-90, 204
swine flu vaccination and, 42-44
synonyms, 34
Td vaccination and, 290
tetanus vaccination and, 16, 87-90, 109, 110, 286, 306
H
Haemophilus influenzae type b (Hib), 62, 97, 236
See also Hib disease, early-onset
Haemophilus influenzae type b vaccine
anaphylaxis and, 262-263
anti-PRP antibodies produced by, 240-241
biologic effects of, 239-241
development of, 236-238
early-onset Hib disease and, 17, 250-256
Guillain-Barré syndrome and, 244-246
thrombocytopenia and, 247-250
transverse myelitis and, 241-243
See also Hib conjugate vaccines
Health and Human Services, U.S. Department of, 2
Hepatitis B
arthritis and, 223-224
chronic carriers, 211
clinical description, 211
fatality rate, 211
polyarteritis and, 224
Hepatitis B vaccination, 4
anaphylaxis and, 17, 228-231, 300
biologic effects of, 213-216
demyelinating diseases and, 17, 219-222
development of, 212-213
Guillain-Barré syndrome and, 216-219
immunization schedules, 213-214, 215
multiple sclerosis and, 220
polyarteritis and, 227
research needs, 306
sudden infant death syndrome and, 231, 299, 300-301
transverse myelitis and, 221, 222, 306
Hib. See Haemophilus influenzae type b
Hib conjugate vaccines, 305
cytopenia and, 247-248
development of, 237-238
early-onset Hib disease and, 16, 256-261, 302
Guillain-Barré syndrome and, 245, 246
immunization schedules, 237-238
See also Haemophilus influenzae type b vaccine
Hib disease, early-onset
causality, 16, 17, 260-261, 263, 302
clinical description, 250
Hib vaccination and, 250-260
risk-modifying factors, 261
Human immunodeficiency virus, 39, 294, 295
Hungary, 191
Hypersensitivity
delayed-type, 62
diphtheria vaccination, 71-72, 100
Schick test, 71-72
I
Immune system
anaphylaxis, 59-61
deficiency, 64-65, 195, 291, 294, 295, 296-297, 299
disease-causing reactions in, classification of, 59
in Guillain-Barré syndrome, 37-38, 44-46
measles vaccination and, 64-65, 294, 295
polio vaccination and, 195, 296-297
response to hepatitis B vaccine, 213-214
response to Hib vaccines, 240-241
response to measles vaccine, 121-122
response to mumps vaccine, 122
response to tetanus toxoid, 95
as risk-modifying factor, 299
type IV reaction, 62
vaccine effects in, 62-65
See also Antibody-antigen reaction
Immunization schedules
diphtheria, 70
diphtheria-pertussis-tetanus, 69-70, 276
Haemophilus influenzae type b, 237-238, 276
hepatitis B, 213, 214-215, 276
mumps, 121
poliomyelitis, 188-189
tetanus, 70
Immunosuppressive measles encephalopathy, 129
Infantile spasms, 16, 17, 53, 78
Infants, measles vaccine-associated thrombocytopenia in, 167-168
Information bias, 21
Injection technique, injury from, 54, 90-91, 93, 293-294
J
Japan, 126, 131, 132-133, 138, 143, 293
K
Koch's postulates of causality, 19
L
M
clinical features, 118
fatality rates, 118
immunosuppressive measles encephalopathy, 129
measles vaccine-strain viral infection, 17, 291
subacute sclerosing panencephalitis and, 51-52
vaccine strain infection, riskmodifying factors, 295
Measles-mumps-rubella vaccination, 5, 64-65, 146, 148
anaphylaxis and, 17, 170-176, 177
aseptic meningitis and, 131-134
diabetes mellitus and, 156-157, 158
egg allergy and, 170-171, 173-174, 176
encephalopathy and, 127, 129, 130
Hib vaccines and, 239, 240, 249, 250
orchitis and, 161-162
residual seizure disorder and, 144
thrombocytopenia and, 164, 165-167, 169-170, 249, 250
Measles vaccination
anaphylaxis and, 170-172, 175-176, 177-178
death and, 17, 176-177, 294, 295
development of, 118-120
diabetes mellitus and, 154, 156, 159
Edmonston strain, 119, 120, 123, 292
encephalopathy and, 123-130
Enders strain, 128
Guillain-Barré syndrome and, 151-153
more-attenuated strain, 119-120, 152
optic neuritis and, 147-149
research needs, 306
residual seizure disorder and, 142-145
Schwarz strain, 120, 126, 129, 143, 149, 292, 293, 294
sensorineural deafness and, 146-147
strains of, 119-120
subacute sclerosing panencephalitis, 135-142
thrombocytopenia and, 164-169, 176-177
transverse myelitis and, 149-151
vaccine-strain viral infection, 17, 177, 295
Wellcome strain, 128
See also Measles-mumps-rubella vaccination
Meningitis
See also Aseptic meningitis
Monitoring System for Adverse Events Following Immunization, 28, 107, 109, 138, 152, 301, 323
arthritis in, 97
fatal outcomes in, 293, 298, 300
Guillain-Barré syndrome in, 88, 218
polio in, 193
Mononeuropathy, 54, 90, 91, 92, 93, 94
Multifactorial causality, 20
causality, 222
clinical description, 36
hepatitis b vaccination and, 220-222, 306
Multivalent vaccines, 5
Mumps, 2
aseptic meningitis and, 49
complications, 121
Mumps vaccination
aseptic meningitis and, 130-135
biologic effects, 122
as cause of anaphylaxis, 175-176, 177
death and, 176-177, 291, 294, 295
development of, 121
diabetes mellitus and, 154-159, 306
Jeryl Lynn strain, 121, 132, 133-134, 135
orchitis and, 160-163
research needs, 306
residual seizure disorder and, 142, 145
sensorineural deafness and, 146-147
thrombocytopenia and, 164-169, 176-177
Urabe strain, 121, 131-132, 133, 134, 135, 306
Myocarditis, 296
N
National Childhood Encephalopathy Study (NCES), 75, 81, 82, 129
National Childhood Vaccine Injury Act, 2, 279
National Collaborative Perinatal Project. 80, 142
National Health Interview Survey, 94, 222
National Health Survey, 226
National Registry for Subacute Sclerosing Panencephalitis, 136, 137 , 140, 141
National Vaccine Injury Compensation Program, 2, 4, 49, 279
National Vaccine Program, 2
Necessary cause, 19
Neomycin sulfate, 174-175, 176
Neuralgic amyotrophy. See Brachial neuritis
Neuritis
brachial, 16, 54-55, 90, 91, 92, 93-94
experimental allergic, 35
optic, 36, 37, 83, 85, 86, 147-149, 220, 221, 222, 306
North West Thames study, 74, 79, 82, 143, 287
O
Odds ratios
brachial neuritis, 93-94
early-onset Hib disease, 261
infantile spasms, 82
subacute sclerosing panencephalitis, 139
sudden infant death syndrome, 276, 295-296
See also Relative risk
clinical description, 37, 83, 147, 220
hepatitis b vaccination and, 221, 222, 306
measles vaccination and, 147-149
tetanus vaccination and, 85, 86
Orchitis
causality, 163
clinical description, 160
measles vaccination and, 160, 163
mumps vaccination and, 160-163
P
Pancreatitis, 155
recommended immunization schedules, 69-70
See also Diphtheria-pertussis-tetanus vaccination
Pharmaceutical manufacturers, 2
Plausibility of causal relation, 5
Polio vaccination
anaphylaxis and, 204-205
biologic effects, 189
death and, 17, 205-206, 298-299
development of, 187-189
Guillain-Barré syndrome and, 17, 200-204, 205, 206
immunization schedules, 189
immunodeficiency as risk factor in, 297
polio caused by, 17, 194-195, 205, 206, 296, 298-299
research needs, 306
risk-modifying factors in, 195
sudden infant death syndrome and, 205-206, 276, 295-296, 299
thrombocytopenia and, 204-205
transverse myelitis and, 196-200
vaccine strain viral infection, 17, 190-195, 205, 206, 296-299
Poliomyelitis, 2
aseptic meningitis and, 49
clinical description, 187, 189
polio vaccine and, 17, 190-195, 205, 206, 296-299
risk modifying factors, 195
Polysaccharide, polyribosylribitol phosphate (PRP), 236-237, 239, 240-241
in postimmunization period, 251-253
See also Haemophilus influenzae type b vaccination
Postinfectious neuritis. See Guillain-Barré syndrome
Postmarketing surveillance, 23, 307
Postvaccinal encephalomyelitis. See Acute disseminated encephalomyelitis
Potential causality, 20-23
Predictive causality, 20, 26-27
Public Health Service, U.S., 4
R
Randomized clinical trial, 30
Recombinant hepatitis B vaccines, 213, 214, 215-216, 223
Rejection of causal relation, 16, 32
Relative risk, 20-21
brachial neuritis, 93-94
case control studies in estimating, 29
of death following measles vaccination, 292
fatal outcomes following DT/Td/tetanus vaccination, 109, 110, 287-290
Guillain-Barré syndrome, 203, 204, 217
hepatitis B vaccination in anaphylaxis, 230-231
Hib vaccination in Hib disease, 261
polio vaccination in SIDS, 295-296
sudden infant death syndrome, 109, 276, 296
Research needs, 17
data, 307-308
diphtheria vaccination, 305
disease registries, 308
Guillain-Barré syndrome, 306-307
hepatitis B vaccines, 222, 306
measles vaccines, 306
mortality data, 307
multiple vaccine administration, 307
mumps vaccines, 306
pertussis vaccines, 317
polio vaccines, 306
risk-modifying factors, 307
rubella vaccines, 317
tetanus toxoids, 305
Residual seizure disorder, 52-53
diphtheria vaccination and, 78-82, 81-82
measles vaccination and, 142-145
mumps vaccination and, 142, 144, 145
tetanus vaccination and, 78-82
vaccine-related fatal outcomes, 293
Retrobulbar neuritis,37
''Retrodictive'' causality, 20, 23-26
Reverse causality bias, 21
Reye syndrome, 76
Rheumatism, 222
Rheumatoid arthritis, 95, 227, 306
Risk-benefit comparisons, 3, 27
Risk difference, 27
Risk-modifying factors
definition, 3
early-onset Hib disease, 261
Guillain-Barré syndrome, 89-90, 204
measles vaccine-strain viral infection, 295
research needs, 307
thrombocytopenia, 169-170
S
Sampling procedures, bias in, 21, 22
See also Residual seizure disorder
Selection bias, 21
Semple vaccine, 44
Sensorineural deafness
causality, 147
clinical description, 146
measles/mumps vaccine and, 146-147
SIDS. See Sudden infant death syndrome
Spontaneous Reporting System, 28
SSPE. See Subacute sclerosing panencephalitis
Stevens-Johnson syndrome, 98, 225
Strength of association, 21
Subacute sclerosing panencephalitis (SSPE), 51-52
causality, 140-142
clinical description, 135
epidemiology, 135-136
measles vaccination and, 135-142
vs. immunosuppressive measles encephalopathy, 129
Sudden infant death syndrome (SIDS), 16, 109-110
diphtheria vaccination and, 109-110, 287
DPT vaccination and, 109, 276, 289, 295, 296
DT vaccination and, 289
epidemiologic data, 276-277
hepatitis B vaccination and, 231, 299, 300-301
Hib vaccination and, 263, 301, 302
measles vaccination and, 291
mumps vaccination and, 291
polio vaccination and, 205-206, 276, 295-296, 299
tetanus vaccination and, 109-110, 287
Sufficient cause, 19
Sweden, 158, 159, 165-166, 172, 201
T
T-lymphocytes, 59
anaphylactic reactions, 101-104, 107, 108
arthritis and, 96-97
as cause of death, 109, 110, 290
diphtheria-tetanus vaccination vs., 73
encephalopathy and, 78
Guillain-Barré syndrome, 88-89
immunization schedule, 69-70, 70
See also Diphtheria vaccination;
Tetanus vaccination
Testitis. See Orchitis
Tetanospasmin, 78
Tetanus vaccination
acute disseminated encephalomyelitis and, 84
arthritis and, 95-97
brachial neuritis and, 16
as cause of death, 109, 110, 287-290
demyelinating diseases and, 83-86
development of, 67-68
erythema multiforme and, 98-99
Guillain-Barré syndrome and, 16, 86-90, 290
infantile spasms and, 16, 81, 82
lot-specific reactions, 305
neuropathy and, 90, 91-92, 93-94
optic neuritis and, 85-86
research needs, 305
residual seizure disorder and, 78-82
sudden infant death syndrome and, 16, 109, 110
transverse myelitis and, 84-86
See also Diphtheria-pertussistetanus vaccination;
Td vaccination
Theoretical plausibility, 5
Thrombocytopenia, 17
causality, 168-169, 205, 249-250
clinical description, 163, 164, 205, 247
fatal outcomes, 294-295
Hib vaccinations and, 247-250
measles-mumps-rubella vaccine and, 17, 164, 167-170, 292, 294-295
measles vaccination and, 164-169
mumps vaccination and, 164-169
platelet destruction in, 168
polio vaccination and, 204-205
risk-modifying factors, 169-170
Thrombocytopenic purpura, 164, 166, 205, 247
Toxic shock syndrome, 172, 175, 176, 293-294
Transverse myelitis, 84-85
causality, 85, 86, 150-151, 199-200, 222, 243
clinical description, 36-37, 83, 149, 196, 219, 241
hepatitis b vaccination and, 221, 222, 306
Hib vaccinations and, 241-243
incidence, 37, 83, 85, 149, 150, 196, 220, 241
measles vaccine and, 149-151
polio vaccination and, 196-200
U
Uncontrolled observational studies, 28-29.
See also Case reports and uncontrolled studies
Underreporting, in VAERS, 282-283
United Kingdom, 75, 126, 131, 140, 143, 145, 191, 193, 237-238, 294
See also National Childhood Encephalopathy Study;
North West Thames study
Urabe strain mumps vaccine, 121, 131-132, 133, 134, 135, 306
Urticaria, 60
V
Vaccine Adverse Event Reporting System, 2, 28, 107, 274, 307
development of, 279
erythema multiforme in, 99
Guillain-Barré syndrome in, 88, 152, 153, 201, 218, 245, 288
measles/mumps vaccination associated with deaths in, 293
meningitis in, 134
mortality data in, 282-286
optic neuritis in, 221
polio vaccinations associated with deaths in, 298
reporting procedures, 279
seizures in. 81
subacute sclerosing panencephalitis in, 138
sudden infant death syndrome in, 276-277, 283-286, 296, 299, 300, 301
thrombocytopenia in, 166-167, 169, 248, 250
transverse myelitis in, 84-85, 150, 198-199, 221, 241, 242, 243
underreporting in, 282-283
Vaccine Injury Table, 48-49, 50, 60, 278, 280-281
Vaccine Safety Committee, 3, 4-5, 16, 278
Viral infection
diabetes mellitus and, 155-156
Guillain-Barré syndrome and, 39